$1.5T FY22 Spending Bill Includes Funding to Address Opioid Epidemic

On March 11th, Congress passed the $1.5 trillion omnibus spending bill, a legislative package to fund the federal government. The package, signed into law by President Biden, includes funding for several federal programs that respond to the opioid epidemic. The spending package extends the temporary scheduling of fentanyl-related substances as Schedule I substances for an additional nine months and extends telehealth flexibilities for five months after the public health emergency expires. The package also includes $572.5 million for communities and first responders to respond to crises like opioid addiction, overdoses, and drug trafficking, $415 million for Comprehensive Addiction and Recovery Act (CARA) grants to support mental health, veteran’s health hand substance use disorder treatment programs administered by correctional facilities, $8 million for the Food and Drug Administration to implement opioid-related strategies, $1.525 billion for the State Opioid Response Grant program, $101 million for medication assisted treatment, $490 million for opioid overdose surveillance and prevention at the Centers for Disease Control and Prevention, $80 million for programs supporting children affected by the opioid epidemic, and $135 million for rural communities.

Articles & Resources

Omnibus Bill Text

Inside Health Policy – House-Passed Omnibus Gives FDA $3.3 Billion For Fiscal 2022

Senator Jeanne Shaheen – Senate Sends Omnibus Package, Including Shaheen Priorities to Address Violence Against Women, Substance Use Disorder Crisis & More, to President’s Desk

Senator Patty Murray – Omnibus Increases Support for Communities and Families Struggling with Mental Health and Substance Use Disorders

Lawmakers Introduce Bills to Address Fentanyl Scheduling and Trafficking

On March 7th, Representatives Chris Pappas (NH-01), Dan Newhouse (WA-04), and Ted Budd (NC-13) introduced the Save Americans from the Fentanyl Emergency (SAFE) Act of 2022. Last May, President Joseph Biden signed into law legislation that extended the Drug Enforcement Agency’s temporary order to keep fentanyl-related substances scheduled as Schedule I drugs under the Controlled Substances Act. The temporary order was extended multiple times throughout 2021 and was most recently extended for another nine months on March 10th when Congress passed the bicameral omnibus spending bill. The SAFE Act of 2022 will amend the Controlled Substances Act to permanently classify fentanyl-related substances that are not already exempted as a Schedule I drug, require that the Attorney General publish a list of fentanyl-related substances, allow the Department of Health and Human Services to conduct research on fentanyl-related substances, and require that the Government Accountability Office publish a report on the effects of permanently scheduling fentanyl-related substances as Schedule I. In a press release, Representative Chris Pappas said, “Permanently scheduling deadly fentanyl analogues is an essential step that will ensure law enforcement retains the tools they need to keep our communities safe and hold traffickers accountable for the harm they have caused.”

On March 9th, Senators Maggie Hassan (NH) and John Cornyn (TX) introduced the Dark Web Interdiction Act. The bill would direct the Sentencing Commission to increase penalties for trafficking illegal drugs through the dark web, make the Joint Criminal Opioid and Darknet Enforcement (J-CODE) task force permanent, and require that the Department of Justice, the Department of Homeland Security, and the Department of Treasury publish a report on the use of virtual currency for opioid trafficking. In a press release, Senator Hassan said, “These dark web marketplaces, which often rely on cryptocurrency for payment, are an increasing threat to our ongoing efforts to stem the flow of fentanyl and other drugs into our communities. I am teaming up with Senator Cornyn to crack down on dealers caught trafficking drugs on the dark web, target international fentanyl trafficking from China and Mexico, and strengthen our overall efforts to disrupt and dismantle these illegal marketplaces.”

Articles & Resources

Save Americans from the Fentanyl Emergency Act of 2022

Representative Chris Pappas – Ahead of March 11 Temporary Scheduling Expiration Date, Pappas, Newhouse, and Budd To Introduce Bipartisan Save Americans from the Fentanyl Emergency Act of 2022

Dark Web Interdiction Act

Senator Maggie Hassan – Senators Hassan, Cornyn Introduce Bipartisan Legislation to Crack Down on Drug Trafficking Through the Dark Web

Upcoming FDA Events Focus on Naloxone Access and Opioid Prescriber Education

Last week, the Food and Drug Administration (FDA) announced two upcoming events focused on sharing information about naloxone access with the public and addressing gaps in existing opioid prescriber education. On March 28, 2022, FDA will hold a virtual public meeting, “Naloxone Access: Answering Questions”, to present frequently asked questions about naloxone access. Healthcare providers, pharmacists, harm reduction specialists, and regulators will share lessons learned on naloxone use. FDA is holding the convening in collaboration with the Reagan-Udall Foundation for the FDA. Those interested in attending the public meeting can register here.

FDA also announced a virtual two-day convening, “Identifying Key Competencies for Opioid Prescriber Education”, which will be held April 4-5, 2022. The convening is a follow-on event from the October 2021 “Reconsidering Mandatory Opioid Prescriber Education Through a Risk Evaluation and Mitigation Strategy (REMS) in an Evolving Opioid Crisis” workshop, and will examine the core competencies to include in existing opioid prescriber education and explore lessons learned and recommendations to improve education efforts. FDA is holding the convening in partnership with the Duke-Margolis Center for Health Policy and will include stakeholders from a variety of sectors, including healthcare, professional associations, federal agencies, and continuing education. Those interested in attending can register here.

Articles & Resources

Margolis-FDA Convening: Identifying Key Competencies for Opioid Prescriber Education

Naloxone Access: Answering Questions

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the issue. Links to relevant articles are provided below.

Department of Justice – ​ 16 Defendants, Including 12 Physicians, Sentenced to Prison for Distributing 6.6 Million Opioid Pills and Submitting $250 Million in False Billings

FDA – FDA Stresses Critical Importance of Safe Disposal of Medications Ahead of National Prescription Drug Take Back Day

FDA – Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse

Law360 – Opioid Victims Get Chance To Confront Sacklers In Court

Politico – Biden again emphasizes help for veterans

STAT – Doctors, companies push to keep looser, pandemic-era rules for prescribing opioid addiction treatment via telemedicine

The Washington Post – Opioid victims confront Purdue Pharma’s Sackler family: ‘It will never end for me’

This Week’s Calendar

In the week ahead, there are no relevant events or hearings noticed at this time. In the event that there are any changes to the schedule for this week, we will make additional information available.

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